1. Disruptive Proposals May Undermine Medicare Part D’s Success, see below for more.
2. PIPC Comments on ICER's Cardiovascular Disease Study, click here to read the letter.
3. Proposed Changes to ICER Framework Available for Comment, click here to view the changes and to comment and see below for more.
4. National Health Council Training on Value Assessment and Patient Voice Rubric, see below for more.
5. Patient-Reported Outcomes Help to Give Patients Better Care, Increased Quality of Life, click here to watch the interview.
6. ICER Announces Possible 2020 Assessments, click here to see the list of possible assessments.
7. AAR Seeks Recruits for Annual Senior Patient and Family Caregivers Network Training, click here to learn more and to apply for the training.
8. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
9. ICER Studies: Acute Migraine, Type 2 Diabetes, Arthritis, Cardiovascular Disease, Duchenne Muscular Dystrophy, Sickle Cell Disease, click here to provide patient input.
10. Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.
Former Senator Blanche Lincoln, a champion in the creation of medicare’s Part D benefit, penned an opinion in Morning Consult calling on policymakers to look to its historical success as a guide to its future. She stated, "A troublesome proposal currently being discussed involves government arbitration within Part D. With this type of system, the government would select a panel to decide the price of a drug. If an agreeable price is not assigned, it is entirely possible that the manufacturer could reduce or stop production of that drug, causing seniors to lose access to many of the prescription drugs they currently rely on — particularly the more modern, innovative treatments approved in recent years...Ultimately, when designing Part D, we took the best of what the government can do and the best of what the private sector can do, and guess who the winner was: seniors....Today we barely pause to marvel at Medicare Part D’s achievement. The program has come in more than 40 percent under budget, while remaining incredibly popular with enrollees.” PIPC also has significant concerns about these policy ideas, which would assign a value to treatments that inherently discriminates against people with disabilities and serious chronic conditions by impeding access to care, whether through non-coverage or through the barriers put in place through utilization management such as step therapy. Putting patients and people with disabilities in the middle is not a solution. Overriding the judgement of clinicians and patients is not the answer. Click here to view the Senator’s opinion. Click here for resources to Value Our Health.
2. PIPC Comments on ICER's Cardiovascular Disease Study
In a letter to the Institute for Clinical and Economic Review (ICER), Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho provided feedback on ICER's draft evidence report on treatments for Cardiovascular disease (CVD). Chairman Coelho argued that there are several key flaws with ICER's report, noting that their model uses inappropriate data for the population being targeted with CVD medications. He also criticized ICER for using an "artificially narrow" definition of a major adverse cardiovascular event. "ICER continues to use a flawed methodology, ignoring real-world data and quality of life outcomes that matter to patients in favor of data that easily crosswalks into the discriminatory QALY metric," wrote Chairman Coelho. "We urge ICER to reconsider both its data sources and its concerning theory that health care must be rationed to achieve savings and efficiency in our health care system." Click here to read the letter.
PIPC also signed onto a comment letter alongside members of the Value and Access Steering Committee addressing ICER's CVD study. Click here to read the letter.
3. Proposed Changes to ICER Framework Available for Comment
ICER has released its proposed changes to its value assessment framework for 2020. Public comment is open on the proposed changes through October 18, 2019. Click here to view the changes and to comment. Click here to view a comment letter signed by over 30 stakeholders. PIPC looks forward to working again with stakeholders to comment on this new opportunity. Click here and here to view videos about ICER's methodology.
4. National Health Council Training on Value Assessment and Patient Voice Rubric
On September 6, the National Health Council (NHC) will hold a training on value assessments for members of the patient community and health policymakers. The PCORI-funded training will address value assessment and its importance to the changing health care landscape. The patient community and how it can participate in value assessments will be a major area of focus. It is open to participants of all experience levels and will incorporate both a beginner and intermediate track. Click here for more information and to register.
NHC also recently released its Rubric to Capture the Patient Voice, a tool for the patient community and other stakeholders can use to evaluate attributes of patient-centeredness and to guide them on meaningful patient engagement. NHC is soliciting feedback from patients and other health care stakeholders. Click here to see the Rubric and to comment.
5. Patient-Reported Outcomes Help to Give Patients Better Care, Increased Quality of Life
Understanding patient-reported outcomes in disease states enhances our ability to provide patients with better care and an increased quality of life, said Dr. Patty Taddei-Allen in an interview with the American Journal of Managed Care. "We want to see how patients are doing, as far as from their disease state, and are these drugs improving their quality of life, as well as helping with the disease. Other areas where patient-reported outcomes have a lot of potential and are currently being used is in the mental health space, in order to be able to identify when maybe there might need to be a change in therapy if there’s a correlation of a decrease in quality of life," she said. Click here to watch the interview.
6. ICER Announces Possible 2020 Assessments
The Institute for Clinical and Economic Research (ICER) published a list of possible assessments for 2020. The possible assessments include drugs to treat cystic fibrosis, breast cancer, multiple sclerosis, and HIV. ICER's QALY-based studies are not transparent, use discriminatory cost-effectiveness measures, and ignore patient preferences and input. Click here to see the list of possible assessments.
7. AAR Seeks Recruits for Annual Senior Patient and Family Caregivers Network Training
Alliance for Aging Research’s Senior Patient and Family Caregiver Network (SP&FCN) is seeking advocates to participate in a research-advocacy training program designed to empower senior patients and their family caregivers to engage in patient-centered outcomes research (PCOR). The training will be held November 19-21, 2019 in Dallas, TX, and reimbursements for a hotel stay and travel expenses are available. In particular, the Alliance is looking for patients or caregivers of patients with Alzheimer’s disease, sarcopenia, atrial fibrillation, chronic pain, age-related macular degeneration, or heart valve disease. Click hereto learn more and to apply for the training.
8. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
- New Zealand: Father urges New Zealand's government to fund cystic fibrosis treatments that would save his son's life. Patients use petitions to put pressure on Pharmac to fund lifesaving drugs.
- Canada: Canadian government continues to refuse to fund lifesaving cystic fibrosis treatments.
- United Kingdom: Patient advocates warn that Britons with asthma do not have accessto new drugs that work better and have fewer side effects. Patients with severe asthma are not getting lifesaving drugs. NICE refuses coverage for drug to treat severely epileptic children.
9. ICER Studies: Acute Migraine, Type 2 Diabetes, Arthritis, Cardiovascular Disease, Duchenne Muscular Dystrophy, Sickle Cell Disease
The Institute for Clinical Economic Review (ICER) conducts cost effectiveness studies for insurers using the cost-per-QALY methodology. ICER provides guidance on its website for patients and patient advocates to provide direct input related to their experiences with the disease. Click here to provide patient input. Click here to view the topics and deadlines. Please note the following upcoming formal ICER deadlines per their website:
- Sickle Cell Disease: Draft Scoping Document and Stakeholder List available, comment period OPEN through 9/20/2019. Meeting 3/26/2020: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for sickle cell disease.
- Arthritis: Model Analysis Plan available. 9/18/2019: Draft Evidence Report. Meeting 11/19/2019: CTAF to an update to its 2017 rheumatoid arthritis assessment.
- Type 2 Diabetes: Model Analysis Plan available. 9/11/2019: Draft Evidence Report. Meeting 11/14/2019: The New England CEPAC will convene to deliberate on ICER's review of oral semaglutide for the treatment of type 2 diabetes.
- Cardiovascular Disease : 9/12/2019: Response to comments, evidence report, and revised voting questions. 9/26/2019 Meeting: Midwest CEPAC to deliberate and vote on ICER's report on evidence presented in ICER's report on additive CVD therapies.
- Unsupported Price Increase Assessment: 10/8/2019: Final Report.
- Acute Migraine: Revised Scoping Document available. 9/6/2019: Research Protocol. Meeting 1/23/2020: Midwest CEPAC to review ICER's assessment of acute migraine treatments
- Valuing A Cure Project: White Paper AVAILABLE. Comment period open 8/6/2019-9/6/2019. Meeting 9/17/2019: Invited stakeholders to discuss single or short-term transformative therapies.
10. Upcoming Events and Webinars
ICER’s Value Framework and Patient Feedback: Q&A with Steve Pearson
September 4, 2019
Click here for details.
Health Spending: Moving from Theory to Action
September 11, 2019
Click here for details.
PCORI Improving Methods Applicant Town Hall
September 12, 2019
Click here for details.
Advisory Panel on Rare Disease Fall 2019 Meeting
September 16, 2019
Click here for details.
PCORI Advisory Panel on Patient Engagement Fall 2019 Meeting
September 17, 2019
Click here for details.
IMPACCT: Real World Evidence
September 18-19, 2019
Click here for details.
2019 PCORI Annual Meeting
September 18-20, 2019
Click here for details.
CMS Public Stakeholder Meeting: Resources to Reduce Opioid Misuse
September 20, 2019
Click here for details.
FT Pharma Pricing and Value Summit 2019
September 26, 2019
Click here for details.
ISPOR Summit 2019 on Building Trust in RWE – The Role of Study Registration
October 11, 2019
Click here for details.
2019 AUCD Annual Meeting
November 17-20, 2019
Click here for details.
11. Medical Journal Articles
Observational Studies Have a Critical Role to Play in Cancer Comparative Effectiveness Research, click here to view.
High-Quality Evidence to Inform Clinical Practice, click here to view.
An Ethical Analysis of Coverage With Evidence Development, click here to view.
How Different Is Research Done by the Patient-Centered Outcomes Research Institute, and What Difference Does it Make?, click here to view.
The Importance of Measuring the Impact of Patient-Oriented Research, click here to view.
Building Evidence and Measuring Clinical Outcomes for Genomic Medicine, click here to view.
Evidence-Based Medicine: A Data-Driven Approach to Lean Healthcare Operations, click hereto view.
Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments, click here to view.
Commonly Used Definitions in Real-World Studies May Underestimate the Prevalence of Renal Disease Among Nonvalvular Atrial Fibrillation Patients, click here to view.
Factors Associated with Evidence-Based Decision-Making Among Patients and Providers, click here to view.
12. AHRQ Effective Program Updates
Research Protocol: Prevention, Diagnosis, and Management of Opioids, Opioid Misuse and Opioid Use Disorder in Older Adults, click here to view.
AHRQ EPC Pilot Projects Summary: Improving Health Systems' Access to High Quality Evidence, click here to view.
Research Protocol: Care Interventions for People With Dementia (PWD) and Their Caregivers, click here to view.
Research Protocol: Impact of Community Health Worker Certification on Workforce and Service Delivery for Asthma and Other Selected Chronic Diseases, click here to view.
AHRQ EPC Program Helps Health Systems Use Evidence, click here to view.
Technical Brief: Pharmacological and Nonpharmacological Treatments for Post-Traumatic Stress Disorder, click here to view.
Systematic Review: Management of Infertility, click here to view.
Key Questions: Cervical Ripening in the Outpatient Setting, click here to view.
Key Questions: Radiation Therapy for Brain Metastases, click here to view.
Protocol: A Rapid Evidence Review of Retention Strategies for Medications for Addiction Treatment (MAT) in Adults with Opioid Use Disorder, click here to view.
Systematic Review: Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention, click here to view.